On Tuesday, 14 March, European ministers had been invited by the Swedish Presidency of the Council of the EU to discuss compromise proposals on the European Commission’s proposal (COM/2022/721, final version) for a regulation on fees and charges payable to the European Medicines Agency (EMA) (see EUROPE 13139/15).
Commissioner for Health and Food Safety Stella Kyriakides stated that she was aware of Member States’ concerns regarding the impact of the European Commission’s proposal on the remuneration of national competent authorities (NCAs).
Mrs Kyriakides believes the European Commission’s proposal ensures stable revenues for the EMA and for NCAs. In the commissioner’s opinion, it is essential that the proposal maintain a certain degree of flexibility so that the fees can be adjusted if necessary while continuing to ensure an appropriate level of funding.
The commissioner added that the delegation of power was, in her view, a tool that would make it possible to deliver this flexibility and to ensure that the system was future-proof. In the commissioner’s opinion, it is important that any changes preserve the principle of cost reflectivity and the proportionality of actual costs.
Member States welcomed the general objective of the European Commission’s proposal as well as the inclusion of procedural costs, which have not been remunerated to date.
Even so, Member States widely supported generally improving the proposal on adjusting fees payable to the EMA. Member States believe the calculation of fees, in the European Commission’s impact assessment, to be based on 2016 data. They want the calculation to be based on current data—taking into account the impact of inflation, Brexit, and the pandemic in particular.
In addition, Member States supported the targeted approach proposed by the Swedish Presidency of the Council of the EU for the review of seven specific procedures.
The [Swedish] Presidency also noted there was broad support for its flexible approach, which includes strengthening the role of the EMA’s Management Board and Member States. In the event that the fees need to be adjusted, the EMA’s Management Board would be responsible for approving a special report serving as the basis for such changes. The report would be prepared by the EMA at the request of the Management Board.
Member States also supported the [Swedish] Presidency’s proposal to clearly define and limit the delegation of power to the European Commission for any changes in fees.
The [Swedish] Presidency also took note of other points raised by certain Member States.
For example, Malta pointed out that if marketing authorisation holders for medicinal products had to pay an additional fee or if they had to do so for each national market, this would be a deterrent for small markets and small-volume medicinal products. This would conflict with the objectives of the pharmaceutical strategy, which is designed to increase access to medicinal products throughout the EU.
Ireland, in particular, wanted thought to be put into very targeted adjustments on medicinal products for veterinary use.
France would like to combine the targeted approach with a ‘high-level’ approach so as to make the amount of the fees for new molecules consistent with those for generic or biosimilar medicinal products.
Belgium would like the incentives for small and medium-sized enterprises to be more dependent on the existence of benefits for public health and society. Belgium would like Member States to be able to compile their own collective report that would serve as the basis for potential fee adjustments and has proposed that such a process be coordinated by an existing group, such as the Heads of Medicines Agencies (HMA).
Commissioner Kyriakides urged legislators to adopt the regulation during the current term.
Cyprus, in particular, believes that the Council of the EU could decide on its position in June. (Original version in French by Émilie Vanderhulst)